CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 289 enrolled
Drug / intervention
Paclitaxel +4 moredrug
Likely dose
Paclitaxel 175 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00737243
NCT00737243Phase 2Completed

A Phase II Study of Chemotherapy Treatment Based on Molecular Profiling Diagnosis for Patients With Carcinoma of Unknown Primary Site

SCRI Development Innovations, LLC·interventional·Posted Aug 18, 2008·Updated Aug 17, 2016

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Carboplatin, and 3 other interventions for Carcinoma. Completed, enrolled 289 participants across 21 sites.

Detailed Summary

This is a non-randomized Phase II study. Patients determined at initial diagnosis to have a carcinoma of unknown primary site (CUP) will have their treatment selected with the use of a molecular profiling assay. The assay will be performed on paraffin-embedded tumor tissue from a biopsy specimen. Patients given specific diagnoses (e.g., lung, pancreas, colon, breast, renal cell, prostate and ovarian cancer) will receive treatment regimens of proven activity. If no specific diagnosis is made with the molecular profiling assay, empiric chemotherapy with paclitaxel, carboplatin, bevacizumab and erlotinib will be administered.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 18, 2008
Enrollment StartAug 1, 2008
Primary CompletionNov 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.9 years ago

Interventions

Paclitaxeldrug

175 mg/m2, 1-3 hour IV infusion Day 1

Carboplatindrug

AUC 6.0 IV Day 1

Bevacizumabdrug

15 mg/kg IV infusion Day 1

Erlotinibdrug

150 mg PO

Treatment determined by physicianother

Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy